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DRUG:

Yescarta (axicabtagene ciloleucel)

i
Other names: FKC876, FKC-876, anti-CD19-CAR PBL, anti-cluster of differentiation 19 (CD19)-CAR PBL, FKC 876, KTE-C19 CAR, anti-CD19 chimeric antigen receptor transduced T cells, KTEC19, KTE-C19, KTE-C19 chimeric antigen receptor T cell therapy
Company:
Cabaret Biotech, Fosun Kite, Gilead, National Cancer Institute
Drug class:
CD19-targeted CAR-T immunotherapy
Related drugs:
1m
Comparative Analysis of Lymphodepletion Regimens in CART-19 Treatment for Relapsed/Refractory Diffuse Large B Cell Lymphoma. (PubMed, Transplant Cell Ther)
Within the limitations of the size of our study and its retrospective nature, flu/cy and bendamustine LD resulted in similar ORR, PFS and OS; however, bendamustine had less hematologic toxicity. Bendamustine can be a viable alternative LD agent for CART-19 therapy for DLBCL, especially in patients with a compromised performance status.
Journal
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CRP (C-reactive protein)
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cyclophosphamide • Yescarta (axicabtagene ciloleucel) • Breyanzi (lisocabtagene maraleucel) • bendamustine • fludarabine IV
1m
Exploring CD19-targeted Immunotherapy Strategies for Human B-cell Lymphoma. (PubMed, Arch Razi Inst)
There are several FDA-approved anti-CD19 CAR-T cells, including Axicabtagene Ciloleucel, Tisagenlecleucel, and Lisocabtagene Maraleucel, as well as anti-CD19 monoclonal antibodies (mABs), such as loncastuximab tesirine and tafasitamab...Blinatumomab, the inaugural FDA-approved antibody to be produced using BiTE technology, has demonstrated notable benefits in clinical trials investigating its use in the treatment of B-cell acute lymphoblastic leukemia (B-ALL)...Furthermore, we engaged in a discourse on the various treatment options concerning CD19 targeting, accompanied by an exposition of the pertinent clinical studies. In this regard, the efficacy, safety, and limitations of each option were thoroughly delineated.
Review • Journal
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CD20 (Membrane Spanning 4-Domains A1) • TNFRSF8 (TNF Receptor Superfamily Member 8) • CD79B (CD79b Molecule) • CD52 (CD52 Molecule)
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Blincyto (blinatumomab) • Yescarta (axicabtagene ciloleucel) • Breyanzi (lisocabtagene maraleucel) • Kymriah (tisagenlecleucel-T) • Zynlonta (loncastuximab tesirine-lpyl) • Monjuvi (tafasitamab-cxix)
1m
Effectiveness of axicabtagene ciloleucel versus conventional treatments as first-line therapy for high-risk large B-cell lymphoma: an external comparator study. (PubMed, BMC Cancer)
In the present study, we leveraged real-world data as a source for external comparator to present clinically meaningful evidence on the comparative effectiveness of axi-cel for treatment of high-risk LBCL.
Clinical • Journal
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MYC (V-myc avian myelocytomatosis viral oncogene homolog) • BCL2 (B-cell CLL/lymphoma 2) • BCL6 (B-cell CLL/lymphoma 6)
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Yescarta (axicabtagene ciloleucel)
1m
Liquid biopsy-directed therapy in primary bone lymphoma: Venetoclax-Pola-R-CHP and CAR-T achieve molecular remission: a case report. (PubMed, Curr Med Res Opin)
The patient received molecularly guided therapy with Pola-R-CHP (polatuzumab vedotin, rituximab, cyclophosphamide, doxorubicin, prednisone) plus venetoclax, achieving complete metabolic remission. Due to the persistent MEF2B and TET2 mutations in ctDNA indicated MRD positive, which prompted she received consolidative CAR-T therapy (axicabtagene ciloleucel)...The BCL2 inhibitor venetoclax has shown good therapeutic effects on DLBCL overexpressing BCL2. An integrated approach incorporating these strategies may improve outcomes for this rare lymphoma subtype.
Journal • Liquid biopsy • IO biomarker
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TET2 (Tet Methylcytosine Dioxygenase 2)
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MYC rearrangement + BCL2 rearrangement • TET2 mutation
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Venclexta (venetoclax) • Rituxan (rituximab) • doxorubicin hydrochloride • cyclophosphamide • Yescarta (axicabtagene ciloleucel) • prednisone • Polivy (polatuzumab vedotin-piiq)
1m
Clinical Impact of LAG3 Single-Nucleotide Polymorphism in DLBCL Treated with CAR-T Cell Therapy. (PubMed, Int J Mol Sci)
LAG3 rs870849 may affect treatment outcome in CAR-T cell therapy, with favorable outcomes in T455 carriers. Specific combinations of CTLA4 and LAG3 germline variants may cooperate to affect the response to CAR-T cell therapy.
Journal • IO biomarker
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LAG3 (Lymphocyte Activating 3)
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Yescarta (axicabtagene ciloleucel) • Breyanzi (lisocabtagene maraleucel) • Kymriah (tisagenlecleucel-T)
1m
Relapsed/Refractory Large B-cell Lymphoma With NT-I7 Post-CD19 CAR T-cell Therapy (clinicaltrials.gov)
P1, N=17, Completed, NeoImmuneTech | Recruiting --> Completed | N=57 --> 17 | Trial completion date: Feb 2026 --> Mar 2025
Trial completion • Enrollment change • Trial completion date
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Yescarta (axicabtagene ciloleucel) • Breyanzi (lisocabtagene maraleucel) • Kymriah (tisagenlecleucel-T) • Hyleukin-7 (efineptakin alfa)
2ms
Tracking Inflammation in CAR-T Therapy: The Emerging Role of Serum Amyloid A (SAA). (PubMed, Cancers (Basel))
Interleukin-6 (IL-6) is widely used to monitor CRS, though its clinical value diminishes after tocilizumab administration... This retrospective study included 43 adults with LBCL treated with axicabtagene ciloleucel... SAA is a robust and dynamic marker of systemic inflammation, with potential utility in both toxicity monitoring and response prediction in the CAR-T setting. Its independence from IL-6 modulation positions it as a promising biomarker for future integration into clinical algorithms.
Journal • IO biomarker
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IL6 (Interleukin 6)
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Yescarta (axicabtagene ciloleucel) • Actemra IV (tocilizumab)
2ms
Targeted therapies and resistance mechanisms in lymphoma: Current landscape and emerging solutions. (PubMed, Oncoscience)
We comprehensively evaluate FDA-approved targeted agents, including monoclonal antibodies (rituximab, brentuximab vedotin, obinutuzumab, mogamulizumab), immune checkpoint inhibitors (nivolumab, pembrolizumab), CAR T-cell therapies (axi-cel, tisa-cel, liso-cel, brexu-cel), bispecific T-cell engagers (mosunetuzumab, epcoritamab), and small-molecule inhibitors (ibrutinib, idelalisib, venetoclax). In conclusion, understanding the molecular basis of lymphoma and resistance mechanisms is critical to optimizing targeted therapy. This review synthesizes current evidence to inform clinical decision-making and outlines future directions for durable, personalized lymphoma care.
Review • Journal • PD(L)-1 Biomarker • IO biomarker
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CD20 (Membrane Spanning 4-Domains A1) • TNFRSF8 (TNF Receptor Superfamily Member 8) • BTK (Bruton Tyrosine Kinase) • CCR4 (C-C Motif Chemokine Receptor 4)
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Keytruda (pembrolizumab) • Opdivo (nivolumab) • Venclexta (venetoclax) • Imbruvica (ibrutinib) • Rituxan (rituximab) • Gazyva (obinutuzumab) • Adcetris (brentuximab vedotin) • Zydelig (idelalisib) • Yescarta (axicabtagene ciloleucel) • Breyanzi (lisocabtagene maraleucel) • Kymriah (tisagenlecleucel-T) • Epkinly (epcoritamab-bysp) • Poteligeo (mogamulizumab-kpkc) • Lunsumio (mosunetuzumab-axgb)
2ms
Germline determinants of toxicity and efficacy in patients with large B-cell lymphoma treated with CAR T-cell therapy. (PubMed, J Immunother Cancer)
Germline genetic aberrations relevant to myeloid cell biology can predict toxicity and efficacy of CART in patients with LBCL. Elucidating such intrinsic determinants may help improve patient selection and develop strategies to enhance the therapeutic index of CART.
Journal
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RAB27A (RAB27A, Member RAS Oncogene Family)
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Yescarta (axicabtagene ciloleucel)
2ms
Patterns of immune recovery after axicabtagene ciloleucel for aggressive B-cell lymphoma. (PubMed, Hemasphere)
Modified EASIX > 2.00 was associated with delayed kinetics of CD3+ T-cells, CD4+ T-cells, and CD8+ T-cells, and cumulative dexamethasone dose > 120 mg with delayed recovery of CD4+ T-cells, NK cells, and IgG. A higher modified EASIX score may predict slower cellular recovery, while corticosteroids may delay both cellular and humoral recovery. Lower CD4+ T-cell count was associated with worse outcomes.
Journal
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CD8 (cluster of differentiation 8) • CD4 (CD4 Molecule)
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Yescarta (axicabtagene ciloleucel)
2ms
Clinical outcome and immunophenotype of axicabtagene ciloleucel (axi-cel) and relmacabtagene autoleucel (relma-cel) in relapsed/refractory large B-Cell lymphoma on Chinese population: a single-center experience. (PubMed, Ann Hematol)
In this cohort, CAR-T therapies for r/r large B-cell lymphoma yielded high response rates and promising survival outcomes, with axi-cel showing superior efficacy but higher CRS incidence compared to relma-cel. The study highlights the need for optimal stem-like memory T-cell proportions in CAR-T products for improved efficacy. Prospective multicenter studies are warranted to confirm these findings in larger patient populations.
Clinical data • Journal • IO biomarker
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CCR7 (Chemokine (C-C motif) receptor 7)
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Yescarta (axicabtagene ciloleucel) • Carteyva (relmacabtagene autoleucel)
2ms
ZUMA-24: Study of Axicabtagene Ciloleucel Given With Steroids In Participants With Relapsed Or Refractory Large B-Cell Lymphoma (clinicaltrials.gov)
P2, N=30, Active, not recruiting, Kite, A Gilead Company | Trial completion date: Mar 2026 --> Dec 2025 | Trial primary completion date: Sep 2024 --> Dec 2025
Trial completion date • Trial primary completion date
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BCL2 (B-cell CLL/lymphoma 2) • BCL6 (B-cell CLL/lymphoma 6) • CXCL8 (Chemokine (C-X-C motif) ligand 8) • CSF2 (Colony stimulating factor 2) • IL15 (Interleukin 15) • IL1R1 (Interleukin 1 receptor, type I) • IL7 (Interleukin 7)
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cyclophosphamide • Yescarta (axicabtagene ciloleucel) • fludarabine IV